REMICADE® and Medicare

REMICADE® and Medicare

Overview of Medicare

Medicare is a federal program that provides health insurance coverage to the following types of people:

  • Individuals over age 65 with a work history
  • Individuals with certain disabilities who have been disabled for at least 2 years
  • Individuals diagnosed with end-stage renal disease (ESRD)

While Medicare covers many healthcare needs, it may not cover all of the patient's healthcare costs. The patient may have to pay a monthly premium for Medicare and then pay a coinsurance and deductible for many services.

Medicare Coverage of REMICADE®

Medicare covers most physician-administered drugs like REMICADE® under Medicare Part B. There are comprehensive published Part B coverage policies specific to REMICADE®. Copies of coverage policies (for example, local coverage determinations, or LCDs) are available on your regional Medicare Administrative Contractor's, or MAC’s Web site.

Medicare typically places few restrictions on REMICADE® coverage. However, some Medicare policies may limit coverage of REMICADE® to certain diagnoses, such as:

  • Crohn's disease
  • Ulcerative colitis
  • Rheumatoid arthritis
  • Ankylosing spondylitis
  • Psoriatic arthritis
  • Plaque psoriasis

You can check your regional MAC Web site for coverage policies for REMICADE® or call Janssen CarePath at 877-CarePath (877-227-3728) for more assistance.

The 4 Parts of Medicare

Medicare is divided into 4 parts: A, B, C, and D. Part A covers facility care such as hospitals, and Part B covers physician and other outpatient services. Part C, which is known as the Medicare Advantage program, allows private managed care plans to administer a patient's Medicare benefits.

Medicare Part D offers prescription drug coverage to anyone enrolled in Medicare Parts A or B. Table 1 provides additional detail regarding the 4 parts of the Medicare program.

Table 1. The 4 Parts of Medicare

Part A

Typically known as the hospital benefit, Part A provides coverage for services such as hospitalizations, hospice care, skilled nursing facility stays, and home health services.

Part B

Part B benefits provide reimbursement for physician services, clinical laboratory services, hospital outpatient services, prescription drugs administered "incident to" a physician's services, durable medical equipment, and some home health services.

Part C

Also known as Medicare Advantage, this benefit provides Medicare Part A, B and often Part D coverage through managed care plans.

Part D

Prescription drug coverage for medicines that are usually self-administered or taken orally.

To learn more about the different parts of Medicare, you can call the Medicare program at 1-800-MEDICARE (1-800-633-4227) or visit Medicare.gov

Our Medicare Resource Guide provides important information for your patients to consider as they are selecting their insurance coverage.

Medicare Part D

Alabama

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross and Blue Shield of Alabama Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Alaska

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Arizona

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross Blue Shield of Arizona Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Health Net Yes 5   See payer for details. For more information
Humana Yes 5   Yes For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Arkansas

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Arkansas Blue Cross and Blue Shield Yes 5, Specialty   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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California

California requires that certain health plans must use the uniform Prior Authorization (PA) Request Form. In addition, there are new rules in California regarding the PA process. The rules are effective October 1, 2014 or January 1, 2015, depending on the type of health plan. Click on the PDF below for more information.

Uniform Prescription Drug Prior Authorization Request Form & Notification Requirements for Health Plans in California

Medicare Part D

Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Anthem Blue Cross of California Yes 5   See payer for details. For more information
Blue Shield of California Yes 6   See payer for details.  
Cigna Yes 5   See payer for details. For more information
Health Net Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Colorado

Colorado requires that certain health plans must use the uniform Prior Authorization (PA) Request Form. In addition, there are new rules in Colorado regarding the PA process. The rules are effective January 1, 2015. Click on the PDF below for more information.

Uniform Prescription Drug Prior Authorization Request Form & Notification Requirements for Health Plans in Colorado

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Anthem Blue Cross Blue Shield of Colorado Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Kaiser Permanente   5      
UnitedHealthcare Yes 5   See payer for details. For more information

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Connecticut

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Anthem Blue Cross Blue Shield of Connecticut Yes 2, 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
ConnectiCare Yes 5   Yes  
UnitedHealthcare Yes 5   See payer for details. For more information

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Delaware

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross Blue Shield of Delaware   Specialty      
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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District of Columbia DC

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Florida

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross and Blue Shield of Florida, Inc./Florida Blue Yes 5   See payer for details. For more information
CarePlus Health Plans, Inc. Yes 5   Yes  
Cigna Yes 5   See payer for details. For more information
Coventry Health Care of Florida Yes 4   See payer for details. For more information
Humana Yes 5   Yes For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Georgia

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross and Blue Shield of Georgia Yes 5, Specialty   See payer for details.  
Cigna Yes 5   See payer for details. For more information
Coventry Health Care of Georgia Yes 5   See payer for details. For more information
Kaiser Permanente   5      
UnitedHealthcare Yes 5   See payer for details. For more information

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Hawaii

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Hawaii Medical Service Association (HMSA) Yes 5   See payer for details.  
UnitedHealthcare Yes 5   See payer for details. For more information

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Idaho

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross of Idaho Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Illinois

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross and Blue Shield of Illinois Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Coventry Health Care of Illinois Yes 5   See payer for details. For more information
Health Alliance Medical Plans Yes 5   Yes  
UnitedHealthcare Yes 5   See payer for details. For more information

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Indiana

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Anthem Blue Cross Blue Shield of Indiana Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Iowa

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Coventry Health Care of Iowa Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information
Wellmark Blue Cross and Blue Shield of Iowa Yes 4   See payer for details. For more information

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Kansas

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross and Blue Shield of Kansas Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Kentucky

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Anthem Blue Cross Blue Shield of Kentucky Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Louisiana

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Maine

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Anthem Blue Cross Blue Shield of Maine Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Maryland

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
CareFirst BlueCross BlueShield Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Massachusetts

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross Blue Shield of Massachusetts Yes 5   See payer for details.  
Cigna Yes 5   See payer for details. For more information
Fallon Community Health Plan Yes 3, 5   Yes  
Harvard Pilgrim Health Care, Inc. Yes 5   See payer for details. For more information
Tufts Health Plan Yes 2   See payer for details.  
UnitedHealthcare Yes 5   See payer for details. For more information

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Michigan

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross Blue Shield of Michigan Yes 5     For more information
Cigna Yes 5   See payer for details. For more information
Health Alliance Plan of Michigan Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Minnesota

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross and Blue Shield of Minnesota Yes 4   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Medica Yes 5   Yes  
UnitedHealthcare Yes 5   See payer for details. For more information

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Mississippi

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Missouri

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Anthem Blue Cross Blue Shield Missouri Yes 5   See payer for details. For more information
BlueCross and BlueShield of Kansas City Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Coventry Health Care of Missouri Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Montana

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross and Blue Shield of Montana Yes 4   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Nebraska

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross and Blue Shield of Nebraska Yes 4   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Nevada

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Anthem Blue Cross and Blue Shield Nevada Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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New Hampshire

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Anthem Blue Cross Blue Shield of New Hampshire Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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New Jersey

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Horizon Blue Cross Blue Shield of New Jersey Yes 5, Specialty   See payer for details.  
UnitedHealthcare Yes 5   See payer for details. For more information

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New Mexico

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross and Blue Shield of New Mexico Yes 5   Yes For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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New York

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
EmblemHealth Yes 4, 5   Yes For more information
Empire BlueCross BlueShield Yes 5   See payer for details. For more information
Excellus BlueCross BlueShield Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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North Carolina

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross and Blue Shield of North Carolina Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information
WellPath, Coventry Health Care of North Carolina Yes 5   See payer for details. For more information

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North Dakota

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross Blue Shield of North Dakota Yes 4   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Ohio

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Anthem Blue Cross Blue Shield of Ohio Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Humana Yes 5   Yes For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Oklahoma

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross and Blue Shield of Oklahoma Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Oregon

Oregon requires that certain health plans must use the uniform Prior Authorization (PA) Request Form. In addition, there are new rules in Oregon regarding the PA process. The rules are effective July 1, 2015. Click on the PDF below for more information.

Uniform Prescription Drug Prior Authorization Request Form & Notification Requirements for Health Plans in Oregon

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Providence Health & Services Yes 6, Specialty   See payer for details. For more information
Regence BlueCross BlueShield Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Pennsylvania

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross of Northeastern Pennsylvania Yes 5, Specialty   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Highmark Blue Cross Blue Shield   5, Specialty     For more information
Independence Blue Cross Yes 4   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Rhode Island

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross & Blue Shield of Rhode Island Yes 2, 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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South Carolina

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
BlueCross BlueShield of South Carolina Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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South Dakota

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information
Wellmark Blue Cross and Blue Shield of South Dakota Yes 5   See payer for details. For more information

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Tennessee

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Texas

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
BlueCross BlueShield of Texas Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Utah

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Altius, Coventry Health Care Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Regence BlueCross BlueShield of Utah Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Vermont

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross and Blue Shield of Vermont Yes 5   See payer for details.  
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Virginia

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Anthem Blue Cross and Blue Shield Virginia Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Washington

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Group Health Cooperative   5     For more information
Health Net Yes 5   See payer for details. For more information
Kaiser Permanente   5      
UnitedHealthcare Yes 5   See payer for details. For more information

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West Virginia

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Highmark Blue Cross Blue Shield West Virginia   Specialty      
UnitedHealthcare Yes 5   See payer for details. For more information

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Wisconsin

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
Gundersen Health Plan Yes 5   Yes For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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Wyoming

Medicare Part D
Payer Prior Authorization Tier Quantity Limits Step
Therapy
Exception & Appeals Process Information
Aetna Yes 5   See payer for details. For more information
Blue Cross Blue Shield of Wyoming Yes 4   See payer for details. For more information
Cigna Yes 5   See payer for details. For more information
UnitedHealthcare Yes 5   See payer for details. For more information

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The information provided presents no statement, promise, or guarantee by Janssen Biotech, Inc., concerning levels of reimbursement, payment, or charge. Please consult your payer organizations with regard to local or actual coverage and reimbursement policies and determination processes.

INDICATIONS

REMICADE® is indicated for:

Crohn's Disease

  • Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy
  • Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD

Pediatric Crohn's Disease

  • Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age or older with moderately to severely active CD who have had an inadequate response to conventional therapy

Ulcerative Colitis

  • Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy

Pediatric Ulcerative Colitis

  • Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy

Rheumatoid Arthritis

  • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX)

Psoriatic Arthritis

  • Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis (PsA)

Ankylosing Spondylitis

  • Reducing signs and symptoms in patients with active ankylosing spondylitis (AS)

Plaque Psoriasis

  • The treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
  • REMICADE® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician

Important Safety Information For REMICADE®

SERIOUS INFECTIONS

Patients treated with REMICADE® (infliximab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue REMICADE® if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with REMICADE®.1,2 Treatment for latent infection should be initiated prior to treatment with REMICADE®.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with REMICADE® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with REMICADE®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.

Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with REMICADE® included pneumonia, cellulitis, abscess, and skin ulceration.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including REMICADE®. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.

Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including REMICADE®. These cases have had a very aggressive disease course and have been fatal. The majority of reported REMICADE® cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with REMICADE® at or prior to diagnosis. Carefully assess the risks and benefits of treatment with REMICADE®, especially in these patient types.

In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including REMICADE®, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with REMICADE® was similar to that expected in the general population whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including REMICADE®. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

CONTRAINDICATIONS

REMICADE® is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. REMICADE® should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue REMICADE® if new or worsening CHF symptoms appear. REMICADE® should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product.

HEPATITIS B REACTIVATION

TNF inhibitors, including REMICADE®, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating REMICADE®. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing REMICADE® for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with REMICADE®. Discontinue REMICADE® in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of REMICADE® and monitor patients closely.

HEPATOTOXICITY

Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported rarely in patients receiving REMICADE® postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, REMICADE® should be discontinued, and a thorough investigation of the abnormality should be undertaken.

HEMATOLOGIC EVENTS

Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to REMICADE® therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of REMICADE® in patients who develop significant hematologic abnormalities.

HYPERSENSITIVITY

REMICADE® has been associated with hypersensitivity reactions that differ in their time of onset. Acute urticaria, dyspnea, and hypotension have occurred in association with infusions of REMICADE®. Serious infusion reactions including anaphylaxis were infrequent. Medications for the treatment of hypersensitivity reactions should be available.

NEUROLOGIC EVENTS

TNF inhibitors, including REMICADE®, have been associated in rare cases with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering REMICADE® in patients with these disorders and consider discontinuation if these disorders develop.

AUTOIMMUNITY

Treatment with REMICADE® may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

ADVERSE REACTIONS

In clinical trials, the most common REMICADE® adverse reactions occurring in >10% of patients included infections (eg, upper respiratory, sinusitis, and pharyngitis),
infusion-related reactions, headache, and abdominal pain.

USE WITH OTHER DRUGS

Concomitant use of REMICADE® with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as REMICADE® is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.

LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS

Live vaccines or therapeutic infectious agents should not be given with REMICADE® due to the possibility of clinical infections, including disseminated infections.

Bring pediatric patients up to date with all vaccinations prior to initiating REMICADE®. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to REMICADE®.

For more information, please see full Prescribing Information and Medication Guide for REMICADE®. Provide the Medication Guide to your patients and encourage discussion. (Requires Adobe® Reader®. Click here to download.)

References:

1. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000;161:S221-S247.

2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.

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